Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Naltrexone, Placebo.
- Кому может быть актуально
- Состояния в реестре: Nonsuicidal Self-Injury. Базовые параметры: от 16 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
Обзор
The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.
Подробное описание
Recruiting participants with nonsuicidal self-injurious behavior and randomizing them to the experiment group and the control group at a 1:1 ratio, the test group administers the experiment drug naltrexone along with the general treatment, and the control group provides a placebo. Clinical evaluation including the frequency of self-injurious behavior is conducted every two weeks. The investigator and participants will double-blinded. Analyze the relationship between changes in clinical symptoms and socio-demographic characteristics, diagnosis, clinical characteristics, and anticipated to discover predictors of treatment effectiveness.
Вмешательства
- Препарат Naltrexone
naltrexone 50mg for 6 weeks - Препарат Placebo
placebo for 6 weeks
Первичные конечные точки
- Frequency of nonsuicidal self-injurous behavior [Срок оценки: 6 weeks]
Вторичные конечные точки (4)
- Deliberate Self-harm Inventory [Срок оценки: 6 weeks]
- Clinical Global Impressions [Срок оценки: 6 weeks]
- Obsessive Compulsive Drinking Scale [Срок оценки: 6 weeks]
- Eating Disorder Examination-Questionnaire [Срок оценки: 6 weeks]
Критерии участия
Критерии включения
- Age: 16 years of age or older
- Clinical interviews meet DSM-5\'s nonsuicidal self-injury diagnostic criteria
- Nonsuicidal self-injurious behavior has been observed more than once in the past two months
- Obsessive Compulsive Drinking Scale general craving item 2 or more points (strong desire)
- Self-injurious behavior continues even with 4 weeks of general psychiatric treatment for underlying disease
- Anyone who can independently read and fill out the questionnaire and speak Korean
- Who understand the written consent and voluntarily agree to participate in the study
- Female participants of childbearing age must be negative on urine pregnancy test at screening
Критерии исключения
- currently in psychotic or manic conditions
- currently experiencing serious suicidal thoughts
- history of substance-related disorders including opioid
- do not agree to use very effective contraception from the time of signing the test subject\'s consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements)
- Severe medical conditions (angina pectoris, myocardial infarction, arrhythmia, any cancer that is not in remission, hypothyroidism, hyperthyroidism, diabetes, hepatitis B, hepatitis C, epilepsy, dementia, HIV infection)
- intellectual disability or organic brain damage
- difficulty reading and writing Korean
- taking opioid antagonists (methadone, buprenorphine, etc.)
- on an opiate painkiller
- currently opiate dependence
- acute opiate withdrawal symptoms
- naloxone-induced test is positive or the urine test is positive for opiates
- have been sensitized to this drug
- acute hepatitis, liver failure, severe liver failure
- renal disease
- hypersensitivity reaction to the main ingredient or other ingredients of this drug
- a pregnant woman, a woman who may be pregnant, or a lactating woman
- Since this drug contains lactose, genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc
- active liver disease
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Seoul National University Hospital — Seoul
Идентификаторы
NCT: NCT06622239 · AYM-NiNsSIB